Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Livanova has determined that certain oxygenators containing a heat-exchanger with a polymer membrane separating the blood compartment from the water compartment when used with the cleaning an disinfection regimen described in the ifu for the heater cooler system 3t (ifu versions applicable since 2013) may result in diffusion of a small quantity of hydrogen peroxide from the water side to the blood side during a typical procedure in a quantity that exceeds the allowable limits determined by livanova.